Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

NCT06145555 | Enrolling By Invitation

• 1 other identifier: Dnr 2023-02223-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited. The overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (CBT-I) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the Stockholm Region. The main hypothesis for the study is that acute psychological sleep stabilization (APS) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that APS also leads to reduced depressive symptoms and earlier discharge. The project includes a pilot study, which will be followed by a randomized, controlled trial of APS compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. APS will be performed by existing staff in the department with the support of a psychologist.

Conditions

Insomnia; Depression

Keywords

CBT; Psychiatry; Inpatient care; Sleep

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  A self-report measure of insomnia symptoms. 7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.

  2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)

Secondary Outcomes (3)

• Patient Health Questionnaire (PHQ-9)

  Day 4, 7, 10 14 and week 4 and 12 post randomisation

• Generalised Anxiety Disorder 7-item scale (GAD-7)

  Day 4, 7, 10 14 and week 4 and 12 post randomisation

• European Quality of Life 5 Dimensions scale (EQ-5D)

  Week 2, 4 and 12 post randomisation

Other Outcomes (4)

• Sleep Diary

  0-14 days post randomisation

• Actigraphy

  0-14 days post randomisation

• Side effects of treatment

  Day 7 and 14 post randomisation

Study Arms (2)

Acute psychological sleep stabilization

EXPERIMENTAL

The basis of the treatment is CBT-I adapted to a short version performed by trained staff (nurses or mental health care assistants) together with a psychologist. The manuals are designed to be read by patients and staff together and each treatment manual covers a specific topic. The focus of the treatment is behavioral changes and central manuals are stimulus control and scheduled sleep and sleep compression (if needed).

Behavioral: Acute psychological sleep stabilization

Sleep hygiene education

ACTIVE COMPARATOR

The control treatment is delivered through structured manuals which patients work through together with the staff. The manuals cover sleep hindering factors (eg coffee, nicotine), sleep promoting factors (eg physical activity during the day, relaxation, blinds), sleep aids (for example, weight blanket, calm music).

Behavioral: Sleep hygiene education

Interventions

Acute psychological sleep stabilization BEHAVIORAL

See above (arm description)

Acute psychological sleep stabilization

Sleep hygiene education BEHAVIORAL

See above (arm description)

Sleep hygiene education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the psychiatric inpatient care (Psykiatri Sydväst)
• Depressive symptoms / confirmed depressive episode (uni- or bipolar)
• Reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase
• Knowledge of Swedish or English that is deemed sufficient to undergo the treatment

You may not qualify if:

• Dementia
• Intellectual disability
• Severe somatic comorbidity with life expectancy \<6 months
• Ongoing mania / mixed-state
• Complex problems that make APS impossible or inappropriate
• Expected discharge within 3 days

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Psykiatri Sydväst, Karolinska Hospital Huddinge

Stockholm, Sweden

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sandra Tamm

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Susanna Jernelöv

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: March 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)